Abstract
BACKGROUND: Intravenous immunoglobulin (IVIg) is widely used to treat primary immunodeficiency, chronic inflammatory demyelinating polyneuropathy, immune thrombocytopenia, and other disorders. Although effective in maintaining IgG trough levels and reducing infections, its safety profile requires further characterization. METHODS: A large-scale pharmacovigilance study was conducted using the U.S. FDA Adverse Event Reporting System (FAERS) from Q1 2004 to Q4 2024. Four disproportionality methods-reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian confidence propagation neural network (BCPNN), and multi-item gamma Poisson shrinker (MGPS)-were applied to detect adverse event signals. Weibull modeling was used to assess temporal risk patterns. RESULTS: A total of 76,138 IVIg-associated reports were identified. Common events included infusion-site reactions (swelling, erythema, pain), infections (upper respiratory tract infection, bronchitis, pneumonia, influenza, urinary tract infection), and systemic reactions (pyrexia, chills, hypersensitivity, headache, asthenia, nausea, vomiting). Several novel potential safety signals emerged, including blood pressure-related events (hypertension and hypotension), weight changes (loss and gain), and falls. CONCLUSION: Real-world FAERS data confirm the established tolerability of IVIg while highlighting rare but clinically important safety signals, particularly hemolytic anemia and aseptic meningitis. These findings warrant further clinical investigation to optimize monitoring and promote safer therapeutic use.